EP0172836A1 - Closed drug delivery system. - Google Patents
Closed drug delivery system.Info
- Publication number
- EP0172836A1 EP0172836A1 EP85900603A EP85900603A EP0172836A1 EP 0172836 A1 EP0172836 A1 EP 0172836A1 EP 85900603 A EP85900603 A EP 85900603A EP 85900603 A EP85900603 A EP 85900603A EP 0172836 A1 EP0172836 A1 EP 0172836A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- capsule
- vial
- flexible
- drug
- container
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
- A61J1/10—Bag-type containers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/1462—Containers with provisions for hanging, e.g. integral adaptations of the container
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2006—Piercing means
- A61J1/201—Piercing means having one piercing end
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2048—Connecting means
- A61J1/2065—Connecting means having aligning and guiding means
Definitions
- the present invention concerns a novel closed drug delivery system enabling a safe and easy reconstitu- tion of a drug just prior to use.
- a diluent may be, for example, a dextrose solution, a saline solution or even water.
- Many such drugs are supplied in powder form and packaged in glass vials.Other drugs, such as some used in chemotherapy, are packaged in glass vials in a liquid state. Powdered drugs may be reconstituted in a wellknown manner, utilizing a syringe which is used to inject liquid into the vial for mixing, the syringe eventually withdrawing the mixed solution from the vial.
- the drug When a drug must be di- luted before delivery to a patient, the drug is often injec ⁇ ted into a container of diluent, where the container may be connected to an administration set for delivery to a pa ⁇ tient. More specifically, the diluent is often packaged in glass bottles, or flexible plastic containers such as are sold under the names MINI-BAGTMand VIAFLEX ® by Travenol
- Drugs may be packaged separately from the diluent for various reasons. One of the most important reasons is that some drugs do not retain their efficacy when mixed with a diluent and thus cannot be stored for any substantial period of time. In some instances the drug and diluent will not stay mixed for a significant length D f time. Also,drugs are often packaged separately from the diluent because many firms which manufacture drugs are not engaged in the busi ⁇ ness of providing medical fluids in containers for intrave- - nous delivery.
- the operator may attempt to solve this by repeatedly injecting solution into the ' vial, mixing and withdrawing the solution but this makes necessary additional injections and movement of the syringe which increase the likelihood of contamination. Also, it is sometimes difficult to get all of the drug and/or liquid out of the vial, thus increasing the time required to perform the reconstitution procedure.
- the reconstitution procedure should be performed under preferably sterile conditions. In addition to such a requirement making the operator justifiably more cautious and consuming more time, sterile conditions are often hard to maintain. In some instances, a laminar flow hood may be required under which the reconstitution procedure is performed.
- Some drugs such as, for example, some chemotherapy drugs, are toxic. Exposure of the operator to the drugs during reconstitution may be dangerous, especially if the operator works with such drugs on a daily basis and is repeatedly exposed to them.
- a further problem is that the reconstitution provides a source of confusion as to which container contains which drug, because the diluent container must be marked with the drug with which it has been injected or at least the name of the patient to whom it should be delivered.
- closed system should prevent water vapor transmission from the receptacle holding the diluent to the receptacle holding the powdered drug.
- a closed system should also be constructed in a manner which will facilitate easy and thorough mixing of the drug and the diluent.
- a closed drug delivery system in which a drug and a diluent are separately stored and selectively mixed used sterile conditions.
- a sterile coupling is utilized which includes a permanently affixed molded junction.
- we have developed a closed drug delivery system that enjoys most of the benefits of the system disclosed in U.S. Patent Nos.
- a closed drug delivery system which comprises a flexible container, a capsule coupled to the flexible container and a drug vial.
- the flexible container has a liquid diluent therein and a delivery outlet.
- the capsule that is coupled to the flexible container has means for supporting the drug vial and has flexible means for enabling movement of the drug vial relative to the supporting means.
- the drug vial has a drug therein, adapted to be mixed with the diluent.
- the drug vial is supported by the supporting means and is adapted for engagement by the flexible means.
- Means couple the capsule to the interior of the flexible container, with the coupling means including means for communicating with the interior of the drug vial.
- the communicating means is out of communication with the , interior of the vial when the vial is in a first position supported by the supporting means.
- the communicating means is in communication with the interior of the vial when the vial has been moved relative to the supporting means and the vial is in another position within the capsule.
- the capsule has a relatively rigid bottom and side walls and the flexible means comprises a flexible member that is sealed at the top of the side walls.
- the flexible member is substantially deformable to enable manual downward movement thereof.
- the flexible member includes a plurality of pleats surrounding a planar central portion, with the flexible member being sealed to the side walls adjacent the periphery of the flexible member.
- the flexible member has a generally circular outline and the capsule carries means for enabling hanging of the capsule.
- the drug vial comprises a standard glass .drug vial bottle having a pierceable stopper retained by a metal band.
- the communicating means comprises a spike for piercing the stopper when the vial is moved onto the spike.
- the supporting means comprise a plurality of legs extending inwardly from the capsule. In one embodiment, the legs extend upwardly from the bottom of the capsule while in another embodiment the legs extend radially inwardly from the side walls of the capsule.
- the coupling means include a frangible member preventing fluid flow unless the frangible member is broken.
- Figure 1 is a perspective view, partially broken for clarity and also showing an opened capsule for clarity, of a closed drug delivery system constructed in accordance with the principles of the present invention.
- Figure 2 is a cross-sectional elevation, taken along the plane of the line 2-2 of Figure 1 , but showing the top of the capsule in its normal, sealed position.
- Figure 3 is a cross-sectional elevation, similar to Figure 2, but showing the drug vial being moved.
- Figure 4 is a cross-sectional elevation, similar to Figure 2, but showing a modified embodiment of the present invention. DETAILED DESCRIPTION OF THE ILLUSTRATIVE EMBODIMENTS
- System 10 includes flexible container 12, preferably formed from flexible plastic (e.g., polyvinyl chloride) sheets having peripheral seals 13, 14, 15 and 16 to define a compressible chamber 18.
- Chamber 18 has a liquid diluent, such as a dextrose solution, a saline solution, or water therein.
- a delivery outlet port 20 communicates with chamber 18 and extends from flexible container 12 at the lowest location thereof. A portion of port 20 is sealed to the container by sealing the lower ends 21 of the plastic sheets against each other and around port 20.
- a plastic capsule 22 is coupled to flexible container 12.
- Capsule 22 has a generally cylindrical configuration, with a bottom 23, side walls 24, and upper rim 26, a pleated top cap 28, and a pair of generally D-shaped hanger members 29, 30.
- the capsule bottom 23, side walls 24 which are formed in a generally circular configuration, rim 26 and hanger members 29, 30 are formed in a one-piece molded construction, while pleated cap 28 is formed separately and is subsequently bonded to rim 26. While cap 28 is illustrated in Figure 1 as being unattached to rim 26, in use the cap 28 has been bonded to rim 26 and the drug delivery system is a closed, sterile system as will be discussed below.
- the bottom 23 and side walls 24 of capsule 22 are relatively rigid, and supporting means in the form of four legs 32, 33, 34 and 35 extend inwardly from side walls 24 of the capsule at the bottom thereof.
- Legs 32-35 support a standard glass drug vial bottle 36 which is located within capsule 22.
- Vial 36 contains a powdered or liquid drug and as is conventional, includes a neck 38 which extends to a rubber-stopped end 40 with the rubber, pierceable stopper being retained by a metal band 42.
- Cap 28 is generally circular and includes three concentric pleats 44 surrounding a planar central portion 46.
- the circumferential portion 48 of cap 28 is sealed to capsule rim 26 by sonic welding or by use of a hot die.
- Cap 28 overlies bottom 50 of vial 36 and is spaced a short distance therefrom, so that when planar portion 46 of cap 28 is manually pressed, it will force vial 36 to move downwardly as will be explained in more detail below.
- Capsule 22 includes an extending outer tube 52 which surrounds a plastic hub 57.
- Hub 57 is overmolded around a one-piece stainless steel needle 54 having a spike tip 55 extending into capsule 22 centrally thereof.
- the other end 56 of hollow needle 54 extends into chamber 18 near the top of the chamber.
- the lower portion of needle 54 is surrounded by a tubular portion 53 of a plastic frangible member 58.
- Tubular portion 53 of the frangible member 58 is secured to needle 54 by either an interference fit between the needle and the tubular portion 53 or by using adhesive or by using adhesive with an interference fit.
- Frangible member 58 comprises the tubular portion 53, a closed fracturable section 60 and ribs 63, similar to the frangible member disclosed in U.S. Patent No.
- the tubular portion 53 When broken at section 60, the tubular portion 53 will be open at its bottom.
- the fracturable member 58 is surrounded by a sleeve 52a which defines two side ports 61 disposed relatively high up in the chamber 18,
- the sleeve 52a. is connected to container 12 by means of heat seal 14 which secures the outer sheets forming container 12 to sleeve 52a , when heat seal 14 is applied.
- ports 61 disposed relatively high up in chamber 18 towards seal 14 increases the size of the flow path of fluid, either gas or liquid, going through needle 54 into chamber 18, so that liquid or air passing through the end 56 of needle 54 can exit end 65 of tube 52a. or can exit from ports 61.
- ports 61 allow for the easy passage of air in chamber 18 back into vial 36. By providing ports 61 relatively high up in the chamber, less air may be maintained in the chamber during manufacture. In other words, container 12 may be manufactured with a higher liquid level.
- side ports 61 in tube 52a_ allow air to be passed back from container 12 into vial 36 in order to pressurize any liquid in vial 36 for returning the liquid back into the chamber 18.
- Figure 4 shows a closed drug delivery system 10' that is similar in most respects to the system of
- FIG. 1-3 except that in the Figure 4 embodiment, four legs 62 (only three of the legs are shown) extend upwardly from the bottom 23 of capsule 22, to support vial 36.
- a hollow, rigid plastic spike 64 is utilized.
- One end 66 of spike 64 communicates with the interior of capsule 22 while the other end 68 of spike 64 communicates with the interior of chamber 18 once the frangible member 58 is broken.
- the flexible container 12 with the diluent and the capsule 22 coupled to flexible container 12, but without cap 28 and vial 36 are steam sterilized.
- the steam sterilized unit, cap 28 and vial 36 are placed in a room that is then sterilized with gas. Once this gas sterilization is accomplished, vial 36 is inserted into the capsule and the cap 28 is hermetically bonded to lip 26 by sonic welding or by the use of a hot die.
Landscapes
- Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Abstract
Un system fermé stérile d'administration de médicament (10) comprend un récipient flexible (12), une capsule (22) couplée au conteneur flexible (12) et une fiole standard de médicament en verre (36) positionnée dans la capsule (22). Le conteneur flexible (12) contient un diluant liquide. La capsule (22) possède des jambes de support (32-35) qui s'étendent vers l'intérieur depuis la capsule (22) pour supporter la fiole (36), et également un chapeau plissé (28) très flexible permettant à la fiole de médicament (36) d'être déplacée manuellement par rapport aux jambes de support (32-35). La capsule (22) est couplée au conteneur flexible (12) à l'aide d'une pointe creuse (54) située dans la capsule (22) et d'un organe cassble (58) situé dans le conteneur flexible (12), l'organe cassable (58) ne permettant le passage du fluid que lorsqu'il est cassé. Une pression manuelle exercée sur le chapeau plissé (28) déplace la fiole de médicament (36) vers le bas contre la pointe (54) qui transperce le bouchon de la fiole de médicament (36). Lorsque l'organe cassable (58) est cassé, il s'établit une communication stérile entre la fiole de médicament (36) et le diluant liquide contenu dans le conteneur flexible (12).A sterile closed drug delivery system (10) includes a flexible container (12), a capsule (22) coupled to the flexible container (12) and a standard glass drug vial (36) positioned in the capsule (22) . The flexible container (12) contains a liquid thinner. The capsule (22) has support legs (32-35) which extend inward from the capsule (22) to support the vial (36), and also a very flexible pleated cap (28) allowing the medicine vial (36) to be moved manually relative to the support legs (32-35). The capsule (22) is coupled to the flexible container (12) using a hollow point (54) located in the capsule (22) and a breakable member (58) located in the flexible container (12), the breakable member (58) allowing the passage of the fluid only when it is broken. Manual pressure on the pleated cap (28) moves the medication vial (36) down against the tip (54) which pierces the stopper of the medication vial (36). When the breakable member (58) is broken, a sterile communication is established between the medicine vial (36) and the liquid diluent contained in the flexible container (12).
Description
Claims
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US06/578,908 US4583971A (en) | 1984-02-10 | 1984-02-10 | Closed drug delivery system |
US578908 | 1990-09-07 |
Publications (2)
Publication Number | Publication Date |
---|---|
EP0172836A1 true EP0172836A1 (en) | 1986-03-05 |
EP0172836B1 EP0172836B1 (en) | 1989-05-31 |
Family
ID=24314818
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP19850900603 Expired EP0172836B1 (en) | 1984-02-10 | 1985-01-23 | Closed drug delivery system |
Country Status (10)
Country | Link |
---|---|
US (1) | US4583971A (en) |
EP (1) | EP0172836B1 (en) |
JP (1) | JPS61501129A (en) |
AU (1) | AU580584B2 (en) |
CA (1) | CA1234369A (en) |
DE (1) | DE3570594D1 (en) |
ES (1) | ES8700944A1 (en) |
IT (1) | IT1183224B (en) |
WO (1) | WO1985003432A1 (en) |
ZA (1) | ZA85835B (en) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP2351596A1 (en) | 2010-01-29 | 2011-08-03 | Fresenius Medical Care Deutschland GmbH | Insert for the infusion of drugs |
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- 1985-01-23 DE DE8585900603T patent/DE3570594D1/en not_active Expired
- 1985-01-23 WO PCT/BE1985/000001 patent/WO1985003432A1/en active IP Right Grant
- 1985-01-23 EP EP19850900603 patent/EP0172836B1/en not_active Expired
- 1985-01-23 AU AU39330/85A patent/AU580584B2/en not_active Expired
- 1985-01-23 JP JP60500696A patent/JPS61501129A/en active Granted
- 1985-02-04 ZA ZA85835A patent/ZA85835B/en unknown
- 1985-02-06 ES ES540177A patent/ES8700944A1/en not_active Expired
- 1985-02-06 CA CA000473686A patent/CA1234369A/en not_active Expired
- 1985-02-08 IT IT1943885A patent/IT1183224B/en active
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP2351596A1 (en) | 2010-01-29 | 2011-08-03 | Fresenius Medical Care Deutschland GmbH | Insert for the infusion of drugs |
WO2011092068A1 (en) | 2010-01-29 | 2011-08-04 | Fresenius Medical Care Deutschland Gmbh | Insert for the infusion of drugs |
US9498615B2 (en) | 2010-01-29 | 2016-11-22 | Fresenius Medical Care Deutschland Gmbh | Insert for the infusion of drugs |
Also Published As
Publication number | Publication date |
---|---|
JPH0349262B2 (en) | 1991-07-29 |
IT1183224B (en) | 1987-10-15 |
WO1985003432A1 (en) | 1985-08-15 |
AU3933085A (en) | 1985-08-27 |
US4583971A (en) | 1986-04-22 |
ES8700944A1 (en) | 1986-11-16 |
ZA85835B (en) | 1985-09-25 |
ES540177A0 (en) | 1986-11-16 |
IT8519438A0 (en) | 1985-02-08 |
CA1234369A (en) | 1988-03-22 |
AU580584B2 (en) | 1989-01-19 |
EP0172836B1 (en) | 1989-05-31 |
JPS61501129A (en) | 1986-06-12 |
DE3570594D1 (en) | 1989-07-06 |
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